Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Contact Force Ablation Catheter
ST. JUDE MEDICAL, INC.
Quartz 65
In Commercial Distribution

  • 07640157990033 ()

  • Catheter Gauge: 7 French
PN-004065

  • Cardiac radio-frequency ablation system catheter
Re-Collapsible Introducer Hydrophillic Coated 12F Comparable Sheath ID 20F Expanded Profile
ST. JUDE MEDICAL, INC.
PRTSOLO-20
Not in Commercial Distribution

  • 25415067028161 ()

  • Catheter Gauge: 20 French
  • Length: 35 Centimeter
PRTSOLO-20

  • Vascular catheter introduction set, nonimplantable
Re-Collapsible Introducer Hydrophillic Coated 11F Comparable Sheath ID 19F Expanded Profile
ST. JUDE MEDICAL, INC.
PRTSOLO-19
Not in Commercial Distribution

  • 25415067028154 ()

  • Length: 35 Centimeter
  • Catheter Gauge: 19 French
PRTSOLO-19

  • Vascular catheter introduction set, nonimplantable
Re-Collapsible Introducer Hydrophillic Coated 12F Comparable Sheath ID 20F Expanded Profile
ST. JUDE MEDICAL, INC.
PRTSOLO-20
Not in Commercial Distribution

  • 15415067028164 ()

  • Catheter Gauge: 20 French
  • Length: 35 Centimeter
PRTSOLO-20

  • Vascular catheter introduction set, nonimplantable
Re-Collapsible Introducer Hydrophillic Coated 11F Comparable Sheath ID 19F Expanded Profile
ST. JUDE MEDICAL, INC.
PRTSOLO-19
Not in Commercial Distribution

  • 15415067028157 ()

  • Length: 35 Centimeter
  • Catheter Gauge: 19 French
PRTSOLO-19

  • Vascular catheter introduction set, nonimplantable
Surface Electrode Kit
ST. JUDE MEDICAL, INC.
EN0020-P
In Commercial Distribution

  • 15415067025934 ()
  • 05415067025937 ()
EN0020-P

  • Cardiac mapping system reference patch
Sizing Balloon II
ST. JUDE MEDICAL, INC.
9-SB-034
In Commercial Distribution

  • 00811806011530 ()

  • Length: 70.0000 Centimeter
  • Outer Diameter: 34.0000 Millimeter
9-SB-034

  • Cardiac sizing catheter
Pulse GeneratorSSIR
ST. JUDE MEDICAL, INC.
2525T
In Commercial Distribution

  • 05414734006224 ()

  • Total Volume: 5.9 Milliliter
2525T

  • Single-chamber implantable pacemaker, rate-responsive
Tiered-therapy cardioverter/defibrillatorVVEV VVIR
ST. JUDE MEDICAL, INC.
1107-36
In Commercial Distribution

  • 05414734502184 ()
  • H7581107360 ()

  • Total Volume: 38 Milliliter
1107-36

  • Single-chamber implantable defibrillator
Tiered-therapy cardioverter/defibrillator VVED DDDR
ST. JUDE MEDICAL, INC.
DR RF
Not in Commercial Distribution

  • H75822073006 ()
  • 05414734501910 ()

  • Total Volume: 38 Milliliter
2207-30

  • Dual-chamber implantable defibrillator
3mm Lead, 60 cm
ST. JUDE MEDICAL, INC.
3228
In Commercial Distribution

  • 05415067017253 ()

  • Outer Diameter: 3 Millimeter
  • Length: 60 Centimeter
3228

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
ADAPTING SLEEVE KIT
ST. JUDE MEDICAL, INC.
4023
In Commercial Distribution

  • 05414734506441 ()

  • Length: 3.2 Millimeter
  • Length: 5 Millimeter
  • Outer Diameter: 6 Millimeter
4023

  • Pacing/defibrillation lead electrical adaptor
Pulse Generator DDDR
ST. JUDE MEDICAL, INC.
DR RF
In Commercial Distribution

  • H758PM221001 ()
  • 05414734503617 ()

  • Total Volume: 12.9 Milliliter
PM2210

  • Dual-chamber implantable pacemaker, rate-responsive
Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
3107-30
Not in Commercial Distribution

  • H75831073006 ()
  • 05414734502214 ()

  • Total Volume: 37 Milliliter
3107-30

  • Cardiac resynchronization therapy implantable defibrillator
Transcatheter Heart Valve
ST. JUDE MEDICAL, INC.
NVRO-35
In Commercial Distribution

  • 05415067045768 ()

  • Outer Diameter: 35.0000 Millimeter
NVRO-35

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
Max Stented Tissue Valve
ST. JUDE MEDICAL, INC.
EMAX-25
In Commercial Distribution

  • 05415067045454 ()

  • Lumen/Inner Diameter: 26.3000 Millimeter
  • Height: 19.0000 Millimeter
EMAX-25

  • Aortic open-surgery heart valve bioprosthesis
Reprocessed ICE Catheter
ST. JUDE MEDICAL, INC.
D087031-R
In Commercial Distribution

  • 05415067041630 ()

  • Length: 90.0000 Centimeter
  • Catheter Gauge: 9.0000 French
D087031-R

  • Intracardiac ultrasound imaging catheter, steerable, reprocessed
No Description
ST. JUDE MEDICAL, INC.
406428
In Commercial Distribution

  • 15415067009460 ()
  • 05415067009463 ()

  • Length: 15 Centimeter
  • Catheter Gauge: 13 French
406428

  • Haemostasis valve obturator
AR 2 Leadless Pacemaker
ST. JUDE MEDICAL, INC.
LSP203A
In Commercial Distribution

  • 05415067051189 ()
LSP203A

  • Intracardiac pacemaker
CUSTOM PACK 0E27R22 ST FRANCIS
MEDTRONIC, INC.
0E27R22
Not in Commercial Distribution

  • 00643169479678 ()


  • Cardiopulmonary bypass system blood tubing set
ADULT ANES CIRC ST. MARYS-SMMC
MEDLINE INDUSTRIES, INC.
DYNJAAF6604
In Commercial Distribution

  • 10889942207909 ()
  • 40889942207900 ()
DYNJAAF6604

  • General surgical procedure kit, non-medicated, single-use
CUSTOM PACK TL7E76R6 ST. LUKES
MEDTRONIC, INC.
TL7E76R6
Not in Commercial Distribution

  • 00643169373679 ()


  • Cardiopulmonary bypass system blood tubing set
ST Infinity 2.0 Staining System
Leica Biosystems Richmond, Inc.
000000000003802098
In Commercial Distribution

  • 00849832027041 ()

  • Device Size Text, specify:


  • Biological stain IVD
CUSTOM PACK 0U59R35 ST THOMAS
MEDTRONIC, INC.
0U59R35
Not in Commercial Distribution

  • 00643169189270 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK 0E27R20 ST FRANCIS
MEDTRONIC, INC.
0E27R20
Not in Commercial Distribution

  • 00643169228252 ()


  • Cardiopulmonary bypass system blood tubing set
C SECTION PACK ST MARYS
MEDLINE INDUSTRIES, INC.
DYNJ45099A
In Commercial Distribution

  • 10889942006892 ()
  • 40889942006893 ()
DYNJ45099A

  • General surgical procedure kit, non-medicated, reusable
CRESCENT KNF B&T ST
Surgical Specialties México, S. de R.L. de C.V.
54-5000
In Commercial Distribution

  • 10848782026590 ()
  • 00848782026593 ()

  • CRESCENT KNF


  • Scalpel, single-use
SLIT KNIFE PARALLEL 3.0MM ST
Surgical Specialties México, S. de R.L. de C.V.
52-2911
In Commercial Distribution

  • 10848782026200 ()
  • 00848782026203 ()

  • 3.0MM


  • Scalpel, single-use
SLIT KNIFE FULL HDL-2.85MM ST
Surgical Specialties México, S. de R.L. de C.V.
52-2801
In Commercial Distribution

  • 10848782026088 ()
  • 00848782026081 ()

  • 2.85MM


  • Scalpel, single-use
ST VINCENT CATH LAB TURNOVER
MEDLINE INDUSTRIES, INC.
DYKC1572
In Commercial Distribution

  • 40193489422994 ()
  • 10193489422993 ()
DYKC1572

  • General surgical procedure kit, non-medicated, single-use
ST JOSEPH GENERAL SURGERY PACK
Cardinal Health 200, LLC
SBA3KGPCAC
In Commercial Distribution

  • 50888439887103 ()
  • 10888439887105 ()
SBA3KGPCAC

  • General surgical procedure kit, medicated
PK CUST LAPAROTOMY PK ST
MEDLINE INDUSTRIES, INC.
DYNJ60952
In Commercial Distribution

  • 10193489537079 ()
  • 40193489537070 ()
DYNJ60952

  • General surgical procedure kit, non-medicated, single-use
TRAUMA PACK CHRISTUS ST E
MEDLINE INDUSTRIES, INC.
DYNJ60907
In Commercial Distribution

  • 10193489536676 ()
DYNJ60907

  • General surgical procedure kit, non-medicated, single-use
PK CUST EXTREMITY ST ELIZ
MEDLINE INDUSTRIES, INC.
DYNJ60896
In Commercial Distribution

  • 10193489536546 ()
DYNJ60896

  • General surgical procedure kit, non-medicated, single-use
TRAY,SKIN PREP,DRY,ST
Cardinal Health 200, LLC
11-7008D
In Commercial Distribution

  • 50888439965122 ()
  • 10888439965124 ()
11-7008D

  • Surgical patient preparation kit
TOTAL JOINT PACK ST VINCENT
MEDLINE INDUSTRIES, INC.
DYNJ60540
In Commercial Distribution

  • 10193489513967 ()
  • 40193489513968 ()
DYNJ60540

  • General surgical procedure kit, non-medicated, single-use
SINGLE BASIN PACK ST VINCENT
MEDLINE INDUSTRIES, INC.
DYNJ60529
In Commercial Distribution

  • 10193489512649 ()
  • 40193489512640 ()
DYNJ60529

  • General surgical procedure kit, non-medicated, single-use
PK CUST CYSTO ST MICHAEL
MEDLINE INDUSTRIES, INC.
DYNJ60545
In Commercial Distribution

  • 10193489511727 ()
  • 40193489511728 ()
DYNJ60545

  • General surgical procedure kit, non-medicated, single-use
PK CUST C-SECTION ST MICH
MEDLINE INDUSTRIES, INC.
DYNJ60544
In Commercial Distribution

  • 10193489511710 ()
  • 40193489511711 ()
DYNJ60544

  • General surgical procedure kit, non-medicated, single-use
PK CUST SHOULDER ST MICHA
MEDLINE INDUSTRIES, INC.
DYNJ60550
In Commercial Distribution

  • 10193489511680 ()
  • 40193489511681 ()
DYNJ60550

  • General surgical procedure kit, non-medicated, single-use
NEURO ANGIO KIT - ST LUKES
MEDLINE INDUSTRIES, INC.
SAMPC0467
In Commercial Distribution

  • 10193489511635 ()
SAMPC0467

  • General surgical procedure kit, non-medicated, single-use
LEFT HEART KIT - ST MARY
MEDLINE INDUSTRIES, INC.
VASC1173
In Commercial Distribution

  • 10193489510843 ()
  • 40193489510844 ()
VASC1173

  • General surgical procedure kit, non-medicated, single-use
KIT, THORACOTOMY ST JOSEPH MAR
Cardinal Health 200, LLC
PG2DTCJHB
In Commercial Distribution

  • 50888439939055 ()
  • 10888439939057 ()
PG2DTCJHB

  • General surgical procedure kit, medicated
C SECTION ST JOSEPH PACK
Cardinal Health 200, LLC
SMA7ACSXX1
In Commercial Distribution

  • 50888439998045 ()
  • 10888439998047 ()
SMA7ACSXX1

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
PK CUST MAJOR ST MICHAEL
MEDLINE INDUSTRIES, INC.
DYNJ60782
In Commercial Distribution

  • 10193489530841 ()
  • 40193489530842 ()
DYNJ60782

  • General surgical procedure kit, non-medicated, single-use
PK CUST CAROTID ST MICHAE
MEDLINE INDUSTRIES, INC.
DYNJ60783
In Commercial Distribution

  • 10193489530735 ()
DYNJ60783

  • General surgical procedure kit, non-medicated, single-use
ST. ANNE'S SHOULDER ARTHR PK
MEDLINE INDUSTRIES, INC.
DYNJC9309I
In Commercial Distribution

  • 10193489525953 ()
DYNJC9309I

  • General surgical procedure kit, non-medicated, single-use
CUSTOM LABEL SHEET ST FRANCIS
MEDLINE INDUSTRIES, INC.
LBL0001235
In Commercial Distribution

  • 40193489520782 ()
  • 10193489520781 ()
LBL0001235

  • General surgical procedure kit, non-medicated, single-use
ST. ANNE'S MINOR BASIN PACK
MEDLINE INDUSTRIES, INC.
DYNJ24622J
In Commercial Distribution

  • 10193489520095 ()
  • 40193489520096 ()
DYNJ24622J

  • General surgical procedure kit, non-medicated, single-use
ST. ANNE'S MULTI PORT PACK
MEDLINE INDUSTRIES, INC.
DYNJ48638C
In Commercial Distribution

  • 10193489519983 ()
DYNJ48638C

  • General surgical procedure kit, non-medicated, single-use
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